A Phase 2 Study of Magnetic Resonance (MR) Imaging With Hyperpolarized Pyruvate (13C) in Patients With Prostate Cancer on Active Surveillance
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Association between intra-tumoral C-pyruvate to lactate (kPL) with Gleason grade
研究概览
简要总结
This phase II trial studies the side how well hyperpolarized carbon C 13 pyruvate (HP C-13 pyruvate) magnetic resonance imaging (MRI) works in monitoring patients with prostate cancer on active surveillance who have not received treatment. Diagnostic procedures, such as MRI, may help visualize HP C-13 pyruvate uptake and breakdown in tumor cells.
详细描述
PRIMARY OBJECTIVES:
I. Optimize the imaging sequences that maximize signal-to-noise ratio (SNR) and intra-tumoral conversion of HP 13C pyruvate to lactate (kPL) and HP 13C pyruvate to glutamate (kPG) in regions of tumor versus (vs.) adjacent benign tissue as assessed by multi-parametric MRI (mpMRI) imaging characteristics. (Part 1) II. Determine the association between intra-tumoral kPL and kPG with Gleason grade determined during magnetic resonance (MR)/ultrasound (US)-guided fusion prostate biopsies obtained within 6 months following baseline HP C-13 pyruvate MR exam. (Part 2)
SECONDARY OBJECTIVES:
I. Evaluate the intra-patient variability in intra-tumoral kPL and kPG with repeated dose studies.
II. Determine the association between peak intra-tumoral kPL observed on baseline imaging with serum prostate specific antigen (PSA).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •The subject has biopsy-proven adenocarcinoma of the prostate with low to intermediate risk disease by UCSF-CAPRA scoring at study entry.
- •For Part 1: Patient planning to enroll or currently on active surveillance; For Part 2: Currently enrolled on active surveillance with planned fusion biopsy within 12 weeks following completion of baseline HP C-13 pyruvate/mpMRI on study.
- •The subject is able and willing to comply with study procedures and provide signed and dated informed consent.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •Absolute neutrophil count (ANC) >= 1000 cells/microliter (uL).
- •Hemoglobin >= 9.0 gm/deciliter (dL).
- •Platelets >= 75,000 cells/uL.
- •Estimated creatinine clearance* >= 50 milliliter (mL)/min by the Cockcroft Gault equation.
- •Total bilirubin =< 1.5 x upper limit of normal (ULN) or if =< 3 x ULN if known/suspected Gilbert's
- •Aspartate aminotransferase (AST) =< 1.5 x ULN.
- •Alanine aminotransferase (ALT) =< 1.5 x ULN.
排除标准
- •Patients without evidence of any prostate cancer on most recent prostate biopsy performed prior to study entry.
- •Current or prior androgen deprivation therapy including luteinizing hormone-releasing hormone (LHRH) analogue or oral anti-androgen therapy. Previous use of a 5-alpha reductase inhibitor is allowed, provided it was discontinued at least 28 days prior to baseline C-13 HP pyruvate MRI
- •Prior radiation treatment of the prostate.
- •Prostate biopsy performed within 14 days prior to baseline C-13 HP pyruvate MRI.
- •Poorly controlled hypertension, with blood pressure at study entry > 160 mm Hg systolic or > 100 mmg Hg diastolic. Treatment with anti-hypertensives and re-screening is permitted.
- •Congestive heart failure with New York Heart Association (NYHA) status >= 2.
研究组 & 干预措施
Diagnostic (HP C-13 MRI)
Patients receive hyperpolarized carbon C 13 pyruvate IV over less than one minute, then undergo MRSI after 1-2 minutes. Within 15-60 minutes, patients may receive optional hyperpolarized carbon C 13 pyruvate and undergo MRSI. Patients also undergo MR/US fusion-guided prostate biopsy within 12 weeks following HP C-13 MRSI.
干预措施: MRI Ultrasound Fusion Guided Biopsy (Procedure)
Diagnostic (HP C-13 MRI)
Patients receive hyperpolarized carbon C 13 pyruvate IV over less than one minute, then undergo MRSI after 1-2 minutes. Within 15-60 minutes, patients may receive optional hyperpolarized carbon C 13 pyruvate and undergo MRSI. Patients also undergo MR/US fusion-guided prostate biopsy within 12 weeks following HP C-13 MRSI.
干预措施: Magnetic Resonance Spectroscopic Imaging (Procedure)
Diagnostic (HP C-13 MRI)
Patients receive hyperpolarized carbon C 13 pyruvate IV over less than one minute, then undergo MRSI after 1-2 minutes. Within 15-60 minutes, patients may receive optional hyperpolarized carbon C 13 pyruvate and undergo MRSI. Patients also undergo MR/US fusion-guided prostate biopsy within 12 weeks following HP C-13 MRSI.
干预措施: Hyperpolarized Carbon C 13 Pyruvate (Drug)
结局指标
主要结局
Association between intra-tumoral C-pyruvate to lactate (kPL) with Gleason grade
时间窗: Within 12 weeks following baseline HP C-13 pyruvate MR exam
kPL will be compared with the pathologic Gleason grade determined using tissue from an MR/US-guided fusion prostate biopsy. Measured kPL will be compared by pathologic Gleason grade using an ANOVA model. If there is an overall difference, the Newman-Keuls post hoc test will be used to determine which tissue pairs differ.
Association between intra-tumoral C-pyruvate to glutamate (kPG) with Gleason grade
时间窗: Within 12 weeks following baseline HP C-13 pyruvate MR exam
kPG will be compared with the pathologic Gleason grade determined using tissue from an MR/US-guided fusion prostate biopsy. Measured kPG will be compared by pathologic Gleason grade using an ANOVA model. If there is an overall difference, the Newman-Keuls post hoc test will be used to determine which tissue pairs differ.
Signal-to-noise ratio (SNR) of hyperpolarized lactate
时间窗: At Baseline
Assessed by multi-parametric magnetic resonance imaging (mpMRI) characteristics.
Intra-tumoral C-pyruvate to lactate (kPL)
时间窗: At Baseline
Assessed by multi-parametric magnetic resonance imaging (mpMRI) characteristics
Intra-tumoral C-pyruvate to glutamate (kPG)
时间窗: At Baseline
Assessed by multi-parametric magnetic resonance imaging (mpMRI) characteristics
次要结局
- Intra-patient variability in kPL(Up to 15 months)
- Intra-patient variability in kPG(Up to 15 months)
- Association between peak intra-tumoral kPL observed on baseline imaging with serum PSA(At Baseline)
- Describe frequency of up-grading of tumor(Within 12 weeks following baseline HP C-13 pyruvate MR exam)
- Contrast between kPL and kPG in regions of tumor(Up to 15 months)
- Comparison of kPL and kPG with apparent diffusion coefficient in region of tumor(Up to 15 months)
- Incidence of adverse events graded(Up to 15 months)
研究者
Ivan de Kouchkovsky, MD
Assistant Clinical Professor
University of California, San Francisco